NDC 0781-8086

Pirfenidone

Pirfenidone

Pirfenidone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Pirfenidone.

Product ID0781-8086_cffd4ce0-9799-4d85-b4c8-93350b82d71d
NDC0781-8086
Product TypeHuman Prescription Drug
Proprietary NamePirfenidone
Generic NamePirfenidone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-05-02
Marketing CategoryANDA /
Application NumberANDA212560
Labeler NameSandoz Inc
Substance NamePIRFENIDONE
Active Ingredient Strength801 mg/1
Pharm ClassesPyridone [EPC], Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0781-8086-92

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92)
Marketing Start Date2022-05-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Pirfenidone" or generic name "Pirfenidone"

NDCBrand NameGeneric Name
0480-3610PirfenidonePirfenidone
0480-3611PirfenidonePirfenidone
0781-2158PirfenidonePirfenidone
0781-8085PirfenidonePirfenidone
0781-8086PirfenidonePirfenidone
16729-467PIRFENIDONEPIRFENIDONE
16729-468PIRFENIDONEPIRFENIDONE
31722-872PirfenidonePirfenidone
31722-873PirfenidonePirfenidone
42385-923PirfenidonePirfenidone
42385-924PirfenidonePirfenidone
42385-925PirfenidonePirfenidone
42385-926PirfenidonePirfenidone
42571-335PirfenidonePirfenidone
42571-336PirfenidonePirfenidone
50228-441PIRFENIDONEPIRFENIDONE
50228-442PIRFENIDONEPIRFENIDONE
50228-443PIRFENIDONEPIRFENIDONE
60219-1640PirfenidonePirfenidone
60219-1641PirfenidonePirfenidone
60219-1642PirfenidonePirfenidone
62332-479PirfenidonePirfenidone
50242-121ESBRIETPIRFENIDONE
50242-122ESBRIETPIRFENIDONE
50242-123ESBRIETPIRFENIDONE
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.